RE: Czech medical grounding?

2003-07-02 Thread Peter L. Tarver

Brent -

60601-1-1 has a requirement for use of an equipotential
bonding terminal when the equipment is either Category AP
Equipment or Category APG Equipment.  These equipment types
are related to flammable mixtures that are used for gaseous
anesthetics and the requirement is intended to reduce the
likelihood of ESD as a source of ignition.  There is no
exception stated for battery powered equipment and neither
should there be, since many anesthetic gases are incredibly
flammable and some are self oxidizing.

If the product in question is Category AP Equipment or
Category APG Equipment, the concern is legitimate.  If not,
it may relate more to the specific use environment in that
particular hospital.

For a reference, see the MSDS for cyclopropane

http://www.matheson-trigas.com/msds/MAT06080.pdf


One line from this MSDS is enough to give pause:

"Electrostatic discharges may be generated by flow or
agitation resulting in ignition or explosion."

eek!


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

> From: brent.dew...@us.datex-ohmeda.com
> Sent: Friday, June 27, 2003 12:26 PM
>
> I got some weird "feedback" from one of our sales
> people in the Czech
> republic.  One of the local folks said they were
> concerned that a metal
> cased piece of medical electrical equipment
> didn't have a separate ground
> for when it was used on internal batteries.  I'm
> an EMC guy so I was
> wondering if any of the safety experts out there
> could tell me if this
> makes any sense from a regulatory standpoint.
>
> Thanks!
>
> Brent DeWitt
>



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RE: Czech medical grounding?

2003-06-30 Thread gd...@ncht.trent.nhs.uk

there is some consideration of this hazard in the EN-60601-1-1 Standard for
Safety of Medical Electrical Systems 
Ged Dean



From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: 29 June 2003 09:51
To: emc-p...@majordomo.ieee.org
Subject: Re: Czech medical grounding?



I read in !emc-pstc that Jon Griver  wrote (in
<3EFEAC1E.19777.64DE86@localhost>) about 'Czech medical grounding?' on
Sun, 29 Jun 2003:

>Theoretically, it could also be necessary for battery powered equipment 
>connected via a 
>communication line to equipment in another room. If the patient were to 
>accidently touch the metal 
>enclosure, a current loop could be closed, if the connection caused the 
>enclosure to be earthed at 
>a potential different from that of other equipment to which the patient may
be 
>connected.

This is more than 'theoretical'. The hazard presented by introducing a
'remote earth/ground' into an area is not documented in any standards or
guides, AFAIK, and is thus not widely recognized.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk

Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
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Re: Czech medical grounding?

2003-06-29 Thread John Woodgate

I read in !emc-pstc that Jon Griver  wrote (in
<3EFEAC1E.19777.64DE86@localhost>) about 'Czech medical grounding?' on
Sun, 29 Jun 2003:

>Theoretically, it could also be necessary for battery powered equipment 
>connected via a 
>communication line to equipment in another room. If the patient were to 
>accidently touch the metal 
>enclosure, a current loop could be closed, if the connection caused the 
>enclosure to be earthed at 
>a potential different from that of other equipment to which the patient may
be 
>connected.

This is more than 'theoretical'. The hazard presented by introducing a
'remote earth/ground' into an area is not documented in any standards or
guides, AFAIK, and is thus not widely recognized.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!


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Re: Czech medical grounding?

2003-06-29 Thread Jon Griver

Brent,

On 27 Jun 2003 at 13:26, brent.dew...@us.datex-ohmeda.com wrote:

> 
> I got some weird "feedback" from one of our sales people in the Czech
> republic.  One of the local folks said they were concerned that a metal
> cased piece of medical electrical equipment didn't have a separate ground
> for when it was used on internal batteries.  I'm an EMC guy so I was
> wondering if any of the safety experts out there could tell me if this
> makes any sense from a regulatory standpoint.
> 

This may be a reference to a Potential Equilization Terminal. This is not
mandated by IEC 60601-1, 
but may be required by local authorities or hospital policy, particularly for
use in operating 
theatres or intensive care units. The terminals on different pieces of
equipment are connected 
together to ensure that all earth potentials are the same in order to prevent
possible current 
loops through the patient.

Theoretically, it could also be necessary for battery powered equipment
connected via a 
communication line to equipment in another room. If the patient were to
accidently touch the metal 
enclosure, a current loop could be closed, if the connection caused the
enclosure to be earthed at 
a potential different from that of other equipment to which the patient may be
connected.

Regards,

Jon Griver
http://www.601help.com
The Medical Device Developers Guide to IEC 60601-1


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Re: Czech medical grounding?

2003-06-28 Thread John Woodgate

I read in !emc-pstc that brent.dew...@us.datex-ohmeda.com wrote (in
) about 'Czech medical grounding?' on Fri, 27 Jun 2003:

>I got some weird "feedback" from one of our sales people in the Czech
>republic.  One of the local folks said they were concerned that a metal
>cased piece of medical electrical equipment didn't have a separate ground
>for when it was used on internal batteries.  I'm an EMC guy so I was
>wondering if any of the safety experts out there could tell me if this
>makes any sense from a regulatory standpoint.

I don't know about regulatory issues, but the equipment could accumulate
a static charge, unless earthed (or bonded, anyway, to everything else
in the area) and zap a patient in a sensitive spot. 
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!


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Czech medical grounding?

2003-06-28 Thread brent.dew...@us.datex-ohmeda.com

I got some weird "feedback" from one of our sales people in the Czech
republic.  One of the local folks said they were concerned that a metal
cased piece of medical electrical equipment didn't have a separate ground
for when it was used on internal batteries.  I'm an EMC guy so I was
wondering if any of the safety experts out there could tell me if this
makes any sense from a regulatory standpoint.

Thanks!

Brent DeWitt



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